Observational Investigation of the CDED in a Real World IBD Clinic

NCT05554445 | Unknown

• 1 other identifier: 0225-21-TLV
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. The diet is composed of three phases, at the end of the first two phases we will evaluate whether the patient achieved remission and at the end of phase three the maintenance of remission. We intend to study achievement and remission rate in association to the diet adaptations made by dieticians at phase 1 and 2, together with patient's choice off food at the third phase under real world clinical setting and patient lifestyle characteristics.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (3)

• Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 1

  Achievement of clinical remission by the end of the first phase of the diet, will be defined as HBI(Harvey-Bradshaw Index)\<4

  week 6, end of phase 1

• Clinical remission rates will be measured by Harvey-Bradshaw Index at the end of phase 2

  Achievement of clinical remission by the end of the second phase of the diet will be defined as HBI(Harvey-Bradshaw Index)\<4

  week 12, end of phase 2

• Rate of patients maintaining clinical remission at the end of phase 3

  Maintaining clinical remission by the end of the third phase of the diet will be defined as HBI(Harvey-Bradshaw Index)\<4

  week 24, end of phase 3

Secondary Outcomes (3)

• Associations between adaptations of the first phase of the diet practiced by IBD dieticians and clinical remission

  week 6

• Associations between adaptations of the second phase of the diet practiced by IBD dieticians and clinical remission

  week 12

• Associations between food choices during the third phase of the diet made by patients and remission maintenance

  week 24

Study Arms (1)

Adult CD patients who are prescribed the Crohn disease exclusion diet

Clinically stable CD patients with active disease by CD symptoms score 4 \<Harvey-Bradshaw index (HBI) at baseline and Calprotectin\>50g/l / endoscopy / imaging proven active disease from the previous 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CD patients who are prescribed the CDED during their routine clinical dietary therapy at the IBD clinic of the TLVMC.

You may qualify if:

• Age \>18 years
• Clinically stable CD patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
• Clinically active disease by CD symptoms score 4 \<Harvey-Bradshaw index (HBI) at baseline and Calprotectin\>50g/l / endoscopy / imaging proven active disease from the previous 4 months.

You may not qualify if:

• Inability to sign informed consent and complete study protocol
• Pregnancy

Sponsors & Collaborators

• Eli Sprecher, MD: lead

Study Sites (2)

Department of Gastroentherology,Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Sourasky medical center (Ichilov)

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal sample

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Nitsan Maharshak, MD

  Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitsan Maharshak, MD

CONTACT

03-6974282; nitsanm@tlvmc.gov.il

Rony Izhar, PhD

CONTACT

ronyi@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of R&D

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: February 21, 2022
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After termination of the study protocol for all participants
• Access Criteria: Medical information and fecal samples would be transferred in an anonymous manner, with no identifying details of the patients

Locations

IL (2)